Prescription medicine
Tapentadol Brand names: Nucynta
Tapentadol (Nucynta) is a prescription medicine with an FDA approval on record since 2008. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $14.48 per tapentadol HCl 100 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the tapentadol FDA label on DailyMed (effective February 26, 2026, Hikma Pharmaceuticals USA Inc.); the NDA 22304 record on Drugs@FDA; every tapentadol label on DailyMed.
Highlights of the record
FDA label of February 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE.
OF tapentadol TABLETS Addiction, Abuse, and Misuse Because the use of tapentadol tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1) ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of tapentadol tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of tapentadol tablets are essential [see Warnings and Precautions (5.2) ]. Accidental Ingestion Accidental ingestion of even one dose of tapentadol tablets, especially by children, can result in a fatal overdose of tapentadol [see Warnings and Precautions (5.2) ]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. […]
Used for
From the label: indications and usageTapentadol tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40kg.
Forms and strengths
- 50 mg
- 75 mg
- 100 mg
- 150 mg
- 200 mg
- 250 mg
- 20 mg/ml
Film-coated tablet; film-coated extended-release tablet; solution.
On the market
- Earliest approval on file
- November 20, 2008 Nucynta, Collegium Pharm Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first January 26, 2026; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 4 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 22, 2029 Nucynta ER tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $14.48 per tablet Tapentadol HCl 100 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 33,272 through July 30, 2026
What is tapentadol used for?
From the label: indications and usageTapentadol tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40kg. […]
Conditions named in the indications of tapentadol's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Opioid Agonist.
Source: FDA drug label (TAPENTADOL), Hikma Pharmaceuticals USA Inc., effective February 26, 2026 (SPL set 863f3fd3-1e8d-41b0-855f-8f9a29237cda), via openFDA; the full label on DailyMed
Is there a generic for tapentadol (Nucynta)?
The FDA approved the first generic tapentadol on January 26, 2026. 4 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 6 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists tapentadol from 4 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 2 patents for Nucynta ER tablets, the last expiring on March 22, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2008 earliest approval on file
- 2026 first generic approved
- 2029 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for tapentadol (Nucynta)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $14.48 per Tapentadol HCl 100 mg tablet. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Tapentadol HCl 50 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tapentadol ER 100 mg tablet | Generic | $21.49 per tablet | $644.60 | n/a |
| Tapentadol ER 200 mg tablet | Generic | $35.31 per tablet | $1,059.37 | n/a |
| Tapentadol ER 50 mg tablet | Generic | $12.37 per tablet | $370.97 | n/a |
| Tapentadol HCl 100 mg tablet | Generic | $14.48 per tablet | $434.39 | n/a |
| Tapentadol HCl 50 mg tablet | Generic | $8.85 per tablet | $265.63 | n/a |
| Tapentadol HCl 75 mg tablet | Generic | $10.65 per tablet | $319.49 | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the tapentadol label say about other medicines?
The tapentadol label names 16 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name tapentadol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Buprenorphine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…) … other opioids (such as oxycodone, hydrocodone, oxymorphone, hydrocodone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression. … |
| Butorphanol | drug interactions | Clinical Impact: May reduce the analgesic effect of tapentadol tablets and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants |
| Cyclobenzaprine | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and … |
| Hydrocodone | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…) … and frequent titration of small doses of other opioids (such as oxycodone, hydrocodone, oxymorphone, hydrocodone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and … |
| Linezolid | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Metaxalone | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and … |
| Methylene blue | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Mirtazapine | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase inhibitors (those intended … |
| Nalbuphine | drug interactions | Clinical Impact: May reduce the analgesic effect of tapentadol tablets and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants |
| Naloxone | drug interactions | Benzodiazepines and other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death [Warnings and Precautions (5.3)]. … (including sedation). If concomitant use is warranted, consider prescribing naloxone for the emergency treatment of opioid overdose [see,,, ]. … |
| Oxycodone | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…) … test doses and frequent titration of small doses of other opioids (such as oxycodone, hydrocodone, oxymorphone, hydrocodone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms … |
| Oxymorphone | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…) … titration of small doses of other opioids (such as oxycodone, hydrocodone, oxymorphone, hydrocodone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory … |
| Phenelzine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…) … pressure and signs and symptoms of CNS and respiratory depression. Examples: phenelzine, tranylcypromine, linezolid |
| Tramadol | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase inhibitors (those intended to treat psychiatric … |
Every other medicine the tapentadol label names
| Medicine named | Section | What the label says |
|---|---|---|
| Tranylcypromine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…) … signs and symptoms of CNS and respiratory depression. Examples: phenelzine, tranylcypromine, linezolid |
| Trazodone | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase inhibitors (those intended to treat … |
Source: FDA drug label (TAPENTADOL), Hikma Pharmaceuticals USA Inc., effective February 26, 2026 (SPL set 863f3fd3-1e8d-41b0-855f-8f9a29237cda), via openFDA; the full label on DailyMed
What do FAERS reports show for tapentadol?
The FDA Adverse Event Reporting System holds 33,272 reports that list tapentadol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 20,613 are coded as a death and 4,501 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2018 (21,688, against a median of 706 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as tapentadol?
36 other medicines are given the same way (oral) and in the same FDA class as tapentadol or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Acetaminophen and hydrocodone | Pain | 38 labelers | $0.152 per tablet 10-325 mg tablet | No current entry |
| Oxycodone | Pain | 34 labelers | $0.0884 per tablet 5 mg tablet | No current entry |
| Acetaminophen and oxycodone | Pain | 30 labelers | $0.183 per tablet 7.5-325 mg tablet | A presentation being discontinued |
| Tramadol | Pain | 40 labelers | $0.0248 per tablet 50 mg tablet | No current entry |
| Morphine | Pain | 17 labelers | $0.226 per tablet 15 mg tablet | In shortage |
| Acetaminophen and codeine | Pain | 25 labelers | $0.256 per tablet 3 tablet | No current entry |
| Hydromorphone | Pain | 11 labelers | $0.219 per tablet 4 mg tablet | In shortage |
| Methadone | Pain | 17 labelers | $0.177 per tablet 10 mg tablet | No current entry |
Every medicine labeled for the same conditions as tapentadol
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does tapentadol compare with medicines for the same use?
4 side-by-side pages set tapentadol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to tapentadol
- 36 medicines for the same use
- Other opioids
- the pharmacologic class, with prices and generics
- Tapentadol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other